The classical end points—overall survival, progression-free survival, and response rate—used in cancer clinical trials have important limitations that not only increase the cost and duration of the drug development process, but can also confound establishment of a statistically significant clinical benefit. This Review discusses these issues, and highlights the urgent need for biomarker-based end points, focusing on those that are under investigations in lung cancer, that closely correlate with disease outcomes and that, therefore, hold promise as surrogates for traditional clinical end points.
- Joel W. Neal
- Justin F. Gainor
- Alice T. Shaw
